Published Nov 05, 2026 | 4:53 PM ⚊ Updated Nov 05, 2026 | 4:53 PM
The Centre has invited objections and suggestions from stakeholders and members of the public within 30 days.
Synopsis: The Union Health Ministry has proposed amendments to the Drugs Rules, 1945, allowing immediate suspension of manufacturers’ licences when their medicines fail critical quality tests, to prevent the continued manufacture and distribution of substandard drugs. The proposal comes amid recurring quality failures, with the Central Drugs Standard Control Organisation flagging 330 entries under the Not of Standard Quality category in September, including six batches of Eli Lilly’s Monjaro KwikPen.
The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to allow the immediate suspension of drug manufacturers’ licences if their medicines fail critical quality tests, including assay, dissolution, sterility and impurity checks.
The proposal seeks to stop manufacturers from continuing to produce and distribute substandard medicines while regulatory proceedings against them are under way.
The draft amendments, notified on 4 November, also require manufacturers to identify the reasons for quality failures and implement corrective measures before their suspended licences can be restored.
The Centre has invited objections and suggestions from stakeholders and members of the public within 30 days of the draft notification being made available in the Gazette.
The proposed changes are aimed at strengthening regulatory oversight and ensuring prompt action against manufacturers whose medicines fail quality standards, the Health Ministry said.
“The proposed amendments seek to enable prompt regulatory intervention upon detection of substandard medicines, prevent their continued manufacture and distribution, and strengthen the mechanism for ensuring compliance with prescribed quality standards, in the interest of patient safety and public health,” the ministry said in a statement.
Also Read: Telangana’s Kamareddy medical college suspends 14 MBBS students over ragging complaint
The proposal comes amid recurring drug-quality alerts issued by the Central Drugs Standard Control Organisation (CDSCO).
In its September 2026 drug-quality alert, CDSCO flagged 330 entries under the NSQ category, alongside a separate entry for a spurious drug.
Among the products flagged were six batches of Eli Lilly’s Monjaro KwikPen, covering all six strengths marketed in India, from 2.5 mg to 15 mg per 0.6 ml. All six entries involved assay-related failures, while certain batches also had sterility and related-substances findings.
The alert also included commonly prescribed medicines, including telmisartan, thyroid tablets, paracetamol, antibiotics, injectable fluids and cough syrups.
Under the existing provisions of the Drugs Rules, 1945, suspension or cancellation of a manufacturing licence is preceded by the prescribed regulatory procedure, including the issuance of a show-cause notice.
The ministry said this could create a time gap between a drug being declared Not of Standard Quality (NSQ) and the initiation of regulatory action. During this period, the medicine could continue to remain in circulation, potentially exposing patients to health risks and making recalls more difficult.
To address this, the draft proposes that the Central Licensing Approving Authority or the State Licensing Authority, as applicable, immediately suspend the manufacturing licence for the concerned drug upon receiving a Government Analyst’s report declaring it NSQ on specified critical parameters.
These include assay, dissolution, related substances, impurities and sterility. Assay measures the quantity of the active pharmaceutical ingredient in a medicine, while dissolution tests how the drug releases its active ingredient. Sterility testing checks for microbial contamination, which is particularly important for injectable medicines.
The proposed amendment also sets conditions for restoring suspended manufacturing licences.
The licence will remain suspended until the manufacturer conducts an effective root cause analysis to identify the reasons behind the quality failure and implements Corrective and Preventive Action (CAPA) to the satisfaction of the licensing authority.
“The suspension of the manufacturing licence … may be revoked by the licensing authority only after the implementation of the Corrective Action and Preventive Action (CAPA) after its due verification by the said authority,” the draft notification states.
This means manufacturers cannot secure restoration of their licences merely by initiating corrective measures. The licensing authority must verify their implementation before revoking the suspension.
The ministry said the mechanism was intended to ensure that identified quality deficiencies are adequately addressed and safeguards are introduced to prevent their recurrence.
The proposed amendments follow deliberations at the 65th meeting of the Drugs Consultative Committee (DCC), held on 20 December 2024, and recommendations made during the 92nd meeting of the Drugs Technical Advisory Board (DTAB) on 24 April 2025.
The draft rules have been issued under the provisions of the Drugs and Cosmetics Act, 1940, after consultation with the DTAB.
The ministry said the amendments would strengthen post-marketing surveillance, facilitate timely action against substandard medicines and promote greater accountability among manufacturers and marketers.
(Edited by Dese Gowda)
